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EC number: 307-055-2 | CAS number: 97489-15-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974-1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No guideline study and non-GLP but performed according to scientific standards at time of performance. Acceptable based on nowadays existing guidlines and standards. Well performed and documented. Reliability declaration regarding procedures and performance available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Two-generation study including a segment II phase for developmental toxicity
- GLP compliance:
- no
- Remarks:
- but reliability declaration from study director included
- Limit test:
- no
Test material
- Reference substance name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- EC Number:
- 307-055-2
- EC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Cas Number:
- 97489-15-1
- Molecular formula:
- H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3
- IUPAC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Reference substance name:
- Hostapur SAS 60
- IUPAC Name:
- Hostapur SAS 60
- Details on test material:
- - Name of test material (as cited in study report): Hostapur SAS 60
- Physical state: aqueous slurry
- Analytical purity: 60%
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 1974-09-01
- Lot/batch No.: NR T 2/112
- Expiration date of the lot/batch: 1979-10-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K.
- Age at study initiation: (P) = weanling rats
- Weight at study initiation: (P) Males: 79 +/- 3g; (P) Females: 87 +/- 3 g
- Fasting period before study: no
- Housing: polypropylene cages
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Humidity (%): 50 +/-20%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): Spratts Laboratory Diet No. 2
- Storage temperature of food: refrigerator
VEHICLE
- Justification for use and choice of vehicle (if other than water): n.a.
- Concentration in vehicle: n.a.
- Amount of vehicle (if gavage): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a. - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 60 days (three pregnancies derived from each of two generations)
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
- After 5 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged separately
- Any other deviations from standard protocol: Approximately 20 days after weaning of the first (A) litters the females were re-mated with different males to produce the second (B) litters. This was repeated a second time to produce the third (C) litters. - Duration of treatment / exposure:
- 60 days prior to mating and throughout three successive pregnancies (fertility)
Gestation days 6 to 15 only for females during organogenesis stage (development) - Frequency of treatment:
- daily
- Duration of test:
- gestation day 6 to 15.
For the P0 study:
F1 parental animals not mated until approximately 10 weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were approximately 15 days of age.
- Age at mating of the mated animals in the study: approximately 13 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Remarks
Doses / Concentrations:
0, 1000, 3000, 10000 ppm
Basis:
nominal in diet
Developmental groups 5, 6, 7
- Dose / conc.:
- 1 000 ppm
- Dose / conc.:
- 3 000 ppm
- Dose / conc.:
- 10 000 ppm
- No. of animals per sex per dose:
- 25 per sex per group
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based on repeated-dose toxicity study and expert judgement
- Rationale for animal assignment (if not random): random
- Other: Intra-uterin development (segment II phase) investigated in groups from F1 and F2 generation
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food intake per cage of five rats was recorded and the mean intake per rat calculated
OTHER: Heamtological investigations, absolute and relative organ weights, histopathological investigation of tissues - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No data - Statistics:
- Mann-Whitney non-parametric U test; chi-squared test incorporating Yates` correction
- Indices:
- Reproductive indices
Mean litter size, mean litter weight, mean offspring weight (day 1, 21, 25), mean offspring weight on
day 4 post partum
Offspring viability indices
Viability index, live birth index - Historical control data:
- OTHER: Heamtological investigations, absolute and relative organ weights, histopathological
investigation of tissues
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Slight body weight gain depression in animals of the highest dose group (10000 ppm) (continously treated)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 ppm (nominal)
- Based on:
- not specified
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: P, F1a, F1b, F2a, F2b (migrated information)
- Dose descriptor:
- NOEL
- Effect level:
- >= 3 000 - <= 10 000 ppm (nominal)
- Based on:
- not specified
- Basis for effect level:
- other: See Remark
- Remarks on result:
- other: other: Generation: F1a, F2b (migrated information)
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Changes in litter size and weights:
- effects observed, non-treatment-related
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 10 000 ppm (nominal)
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOEL
- Effect level:
- >= 10 000 ppm (nominal)
- Sex:
- not specified
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Key result
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Treatment during organogenesis (gestation days 6 to 15) up to 10000 ppm gave no indication of embryotoxicity or teratogenicity (neither in F1-generation nor in F2-generation).
- Executive summary:
Continous administration of sec-alkane sulfonate-sodium salts SAS to male and female rats at dietary concentrations of 1000 ppm, 3000 ppm or 10000 ppm was associated with a slight depression of bodyweight gain in male rats throughout the F0 and F1 generation. Treatment during organogenesis (gestation days 6 to 15) at dietary concentrations up to 10000 ppm gave no indication of teratogenic responses in either generation.
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